Drug administration in people with swallowing difficulties (dysphagia), particularly the elderly, is challenging. For example, residents in extended care facilities take an average of nine medications daily, ranging from vitamins to support an anti-osteoporosis regimen, through to cardio-vascular medications of varying types—blood pressure, cholesterol lowering, diabetes medications and so on. Typical drug administration is three or even four times a day. Thirty-five percent of patients in these facilities have difficulty swallowing.
Solid oral dosage forms (e.g. pills or tablets etc.) come in a variety of size, shapes, textures and coatings and are generally unpleasant and time consuming to administer, even for people who can manage to swallow them, due to size, stickiness, taste, aftertaste or frequency of administration. In people who have dysphagia, swallowing solid oral dosage forms may be very painful, if not impossible (e.g. stroke patients).
A standard method of drug administering solid oral medications such as tablets and pills is to grind them using a crushing device (manual or motorized) and mix them with whatever food the patient will tolerate. This process disrupts the fundamental behavior of the medicine. For the patient, it can result in toxicity if the drug is absorbed quicker than usual or if the blood concentration becomes too high (dose dumping). The drug effects (desirable clinical effects) may wear off quicker than usual, leaving the patient ‘unmedicated’ until the next dose. It also results in unpleasant experiences for patients due to bad taste or unpleasant texture making administration even more challenging for staff. Crushing pills can result in dosing inaccuracy as powdered drug can be left behind in the crushing device or lost during transfer to the food. The process of crushing can aerosolize the drug and it can be inhaled by staff or patients, a clear safety issue. Crushing pills by staff can result in repetitive strain or other workplace injury, a significant logistical and economic problem for facilities. In addition, among many other problems, grinding and mixing medications results in exposure of the active pharmaceutical ingredient (API) to an environment it was not designed or approved for, in terms of acidity, temperature, liquid exposure, dissolution outside of the patient's own body, and other factors. Compounding this problem, long acting formulations of some drugs have been developed to reduce the frequency of administration to once daily from 2-4 times daily; these long acting pills that cannot be ground up because to do so would release a potentially dangerous bolus of medications to the patient. Yet this is consistently the primary method by which drugs are administered to these challenging patients.
There is a need in the art for pharmaceutical compositions that are easily taken by subjects with difficulty swallowing and methods of making and administering these compounds.